Capecitabine

Product NDC
51407-640
11-digit product format
514070640
Labeler code
51407
Product ID
51407-640_4f9bc480-ac67-aef4-e063-6394a90aa9a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Capecitabine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA091649
Marketing category
ANDA
Marketing start
2013-09-16
Substance
CAPECITABINE
Active strength
500 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Capecitabine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPECITABINE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6804DJ8Z9U
Rxcui200327, 200328

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a5eae620-c3a7-41bb-55a8-fce9c3eb9864Product name920180820

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-640-12Capecitabine120 in 1 BOTTLETABLET, FILM COATED1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-640CAPECITABINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4Current NDC, Legacy NDC, 1 package rows20250522_e28a5ef7-4731-f8ac-e053-2995a90a21bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSNe28a5ef7-4731-f8ac-e053-2995a90a21bf5
200328capecitabine 500 MG Oral TabletPSNe28a5ef7-4731-f8ac-e053-2995a90a21bf5
200327capecitabine 150 MG Oral TabletSCDe28a5ef7-4731-f8ac-e053-2995a90a21bf5
200328capecitabine 500 MG Oral TabletSCDe28a5ef7-4731-f8ac-e053-2995a90a21bf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-640-1251407064012120 TABLET, FILM COATED in 1 BOTTLE (51407-640-12) 2022-06-280000-00-00NoNoCurrent